Trial Information

MITO-16 - MANGO-OV2 is a single-arm, open-label, non-comparative, multicenter, phase IV
study. Patients will receive a combination of bevacizumab, paclitaxel and carboplatin as
first line treatment (in-label dose and scheduling). This is an exploratory study attempting
to identify potential prognostic clinical factors(such as hypertension) and prognostic
biologic factors. Overall, 2 types of biomarkers are considered. Dynamic biomarkers are
those expressing the changing nature of the disease in relation to the treatment or simply
the tumour progression, these are typically not inherited. Genetic biomarkers are typically
inherited and are expression of some characteristics potentially able to interfere with the
treatment effect (i.e. Pharmacogenomics).

The safety of this regimen in routine clinical practice will also be described.

- Other malignancy within the last 5 years, except for adequately treated carcinoma in
situ of the cervix or squamous carcinoma of the skin, or adequately controlled
limited basal cell skin cancer.

Other-treatment related

- Any prior radiotherapy to the pelvis or abdomen.

- Surgery (including open biopsy) within 4 weeks prior to the first bevacizumab dose or
planned (In this case the patient can be enrolled but the administration of
bevacizumab should be omitted at first cycle).

- Current or recent (within 10 days prior to the first study drug dose) use of
full-dose oral or parenteral anticoagulant or thrombolytic agent for therapeutic
purposes (except for central venous access patency, in which case international
normalized ratio [INR] must be maintained below 1.5). Post operative prophylaxis with
low molecular weight heparin sc is allowed.

- Current or recent (within 30 days of first study dosing) treatment with another
investigational drug.

- Proteinuria >1g in a 24-hour urine collection (to be performed only among patients
who showed a ≥3+ at urine dipstick).

Patient related

- Pregnant or lactating patients.

- History or evidence of thrombotic or hemorrhagic disorders; including cerebrovascular
accident (CVA) / stroke or transient ischemic attack (TIA) or sub-arachnoid
haemorrhage within ≤6 months prior to the first study treatment).

- History of abdominal fistula, gastrointestinal perforation, or intra-abdominal
abscess within 6 months prior to the first study treatment.

- Non-healing wound, ulcer or bone fracture. Patients with granulating incisions
healing by secondary intention with no evidence of fascial dehiscence or infection
are eligible but require three weekly wound examinations.

- Evidence of any other medical conditions (such as psychiatric illness, peptic ulcer,
etc.), physical examination or laboratory findings that may interfere with the
planned treatment, affect patient compliance or place the patient at high risk from
treatment-related complications.

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